Intrathecal DepoCyte and Lineage-targeted Minimal Residual Disease-oriented Therapy of Acute Lymphoblastic Leukemia
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Northern Italy Leukemia Group.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Northern Italy Leukemia Group
Information provided by:
Northern Italy Leukemia Group
ClinicalTrials.gov Identifier:
NCT00795756
First received: November 19, 2008
Last updated: March 31, 2011
Last verified: March 2011
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Purpose
The aim of this clinical study in adult ALL is to compare by risk category (1) the feasibility of two different CNS prophylaxis regimens and (2) the overall disease-free survival in relation to the achievement of an early MRD negative status and following consolidation with lineage-targeted methotrexate infusions and other disease-specific therapeutic elements, with or without the application of allogeneic or autologous SCT depending on risk class and MRD study results.
In this multicentric prospective pilot randomized phase II trial on CNS prophylaxis, all patients receive induction/consolidation therapy incorporating lineage-targeted high-dose methotrexate plus other drugs (with additional imatinib in Ph/BCR-ABL+ ALL), for the achievement of an early negative MRD status. The MRD study supports a risk/MRD-oriented final consolidation phase.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Lymphoblastic Leukemia |
Drug: liposome-encapsulated cytarabine (DepoCyte) Drug: Triple intrathecal therapy (TIT) |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Study on CNS Prophylaxis With Liposome-Encapsulated Cytarabine in Association With a Lineage-Targeted and MRD-Oriented Postremission Strategy in Adult ALL |
Resource links provided by NLM:
Further study details as provided by Northern Italy Leukemia Group:
Primary Outcome Measures:
- Comparative analysis of feasibility/toxicity of IT DepoCyte vs. TIT [ Time Frame: weeks 5, 11, 17 and 23 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Comparative analysis of isolated and combined CNS recurrence following TIT vs DepoCyte prophylaxis [ Time Frame: During study follow-up ] [ Designated as safety issue: No ]
- Complete remission (CR) [ Time Frame: After study chemotherapy cycles 1 and 2 ] [ Designated as safety issue: No ]
- Bone marrow MRD negativity rates [ Time Frame: Four time-points at weeks 4-22 ] [ Designated as safety issue: No ]
- Lenght of remission [ Time Frame: Study follow-up ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Study follow-up ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intrathecal DepoCyte
I.t. DepoCyte 50 mg admninistered x6-8 (depending on immunophenotypic disease subset) during induction/consolidation/eraly maintenance phases
|
Drug: liposome-encapsulated cytarabine (DepoCyte)
DepoCyte 50 mg injected intrathecally x6-8 (6: B-lineage, 8: T-lineage) during induction/consolidation phases
Other Names:
|
|
Active Comparator: Triple intrathecal therapy (TIT)
Methotrexate 12,5 mg + Cytarabine 50 mg + Prednisolone 40 mg injected intrathecally x12 during indiction/consolidation phases
|
Drug: Triple intrathecal therapy (TIT)
Methotrexate 12,5 mg + Cytarabine 50 mg + Prednisolone 40 mg. injected intrathecally x12 during induction/consolidation therapy
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 18-65 years.
- Diagnosis of untreated ALL with B-/T-precursor phenotype or B-cell lymphoblastic lymphoma (B-LL), either de novo or secondary to chemo-radiotherapy for other cancer.
- Full cytological, cytochemical, cytogenetic and immunobiological disease characterization by revised FAB, EGIL and WHO criteria.
- Bone marrow and peripheral blood sampling (ALL) or biopsy specimen (LL) for MRD study.
- ECOG performance status 0-2 or reversible ECOG 3 score following intensive care of complications.
- Signed informed consent.
Exclusion Criteria:
- Diagnosis of B-ALL (FAB L3 ALL/Burkitt's leukemia or lymphoma) and T-LL (T-cell lymphoblastic lymphoma).
- Down's syndrome.
- Pre-existing, uncontrolled pathology such as cardiac disease (congestive/ischemic, acute myocardial infarction within the past 3 months, untreatable arrythmias, NYHA classes III and IV), severe liver disease with serum bilirubin >3 mg/dL and/or ALT >3 x upper normal limit (unless attributable to ALL/LL), kidney function impairment with serum creatinine >2 mg/dL (unless attributable to ALL/LL), and severe neurological or psychiatric disorder that impairs the patient's ability to understand and sign the informed consent, or to cope with the intended treatment plan.
- Known HIV positive serology.
- Other active hematological or non-hematological cancer with life expectancy <1 year.
- Pregnancy (fertile women will be advised not to become pregnant while on treatment; and male patients to adopt contraceptive methods), unless therapeutic aborption/early discharge is carried out.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00795756
Contacts
| Contact: Roberto Marchioli, MD | 0039-(0)872-570250 | marchioli@negrisud.it |
Locations
| Italy | |
| USC Ematologia, Ospedale Civile | Active, not recruiting |
| Alessandria, (al), Italy | |
| USC Ematologia, Ospedali Riuniti | Recruiting |
| Bergamo, (bg), Italy, 24128 | |
| Contact: Renato Bassan, MD 0039-(0)35-269492 rbassan@ospedaliriuniti.bergamo.it | |
| Principal Investigator: Renato Bassan, MD | |
| Sub-Investigator: Tamara Intermesoli, MD | |
| Sub-Investigator: Alessandro Rambaldi, MD | |
| Sub-Investigator: Orietta Spinelli, B. Sci. | |
| Divisione di Ematologia - Spedali Civili | Not yet recruiting |
| Brescia, (bs), Italy | |
| Contact: Giuseppe Rossi, MD | |
| Principal Investigator: Giuseppe Rossi, MD | |
| Sub-Investigator: Erika Borlenghi, MD | |
| Divisione di Ematologia e TMO, Ospedale San Maurizio | Recruiting |
| Bolzano, (bz), Italy | |
| Contact: Sergio Cortelazzo, MD | |
| Principal Investigator: Sergio Cortelazzo, MD | |
| Sub-Investigator: Irene Cavattoni, MD | |
| Sub-Investigator: Vincenzo Cassibba, MD | |
| Ematologia e centro TMO - Ospedale Armando Businco | Not yet recruiting |
| Cagliari, (ca), Italy | |
| Contact: Emanuele Angelucci, MD | |
| Principal Investigator: Emanuele Angelucci, MD | |
| Sub-Investigator: Claudio Romani, MD | |
| S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle | Recruiting |
| Cuneo, (cn), Italy | |
| Contact: Daniele Mattei, MD | |
| Principal Investigator: Daniele Mattei, MD | |
| Sub-Investigator: Andrea Gallamini, MD | |
| Ematologia e centro TMO, Istituti Ospedalieri | Not yet recruiting |
| Cremona, (cr), Italy | |
| Contact: Sergio Morandi, MD | |
| Principal Investigator: Sergio Morandi, MD | |
| Ematologia - AOU Careggi | Not yet recruiting |
| Firenze, (fi), Italy | |
| Contact: Alberto Bosi, MD | |
| Sub-Investigator: Franco Leoni, MD | |
| Sub-Investigator: Giacomo Gianfaldoni, MD | |
| Sub-Investigator: Francesco Mannelli, MD | |
| Principal Investigator: Alberto Bosi, MD | |
| Ematologia e centro TMO - IRCSS Mangiagalli Regina Elena | Recruiting |
| Milano, (mi), Italy | |
| Contact: Giorgio Lambertenghi-Deliliers, MD | |
| Principal Investigator: Giorgio Lambertenghi-Deliliers, MD | |
| Sub-Investigator: Agostino Cortelezzi, MD | |
| Sub-Investigator: Angelo Cardellini, MD | |
| Ematologia e centro TMO, Ospedale San Raffaele | Recruiting |
| Milano, (mi), Italy | |
| Contact: Fabio Ciceri, MD | |
| Principal Investigator: Fabio Ciceri, MD | |
| Sub-Investigator: Stefania Trinca, MD | |
| Ematologia e centro TMO, Ospedale San Gerardo | Recruiting |
| Monza, (mi), Italy | |
| Contact: Enrico Pogliani, MD | |
| Principal Investigator: Enrico Pogliani, MD | |
| Sub-Investigator: Elisabetta Terruzzi, MD | |
| Sub-Investigator: Monica Fumagalli, MD | |
| Sub-Investigator: Luisa Verga, MD | |
| Oncoematologia e TMO - Dipartimento Oncologico La Maddalena | Not yet recruiting |
| Palermo, (pa), Italy | |
| Contact: Maurizio Musso, MD | |
| Principal Investigator: Maurizio Musso, MD | |
| Ematologia 2 - Ospedale San Giovanni Battista | Recruiting |
| Torino, (to), Italy | |
| Contact: Filippo Marmont, MD | |
| Principal Investigator: Filippo Marmont, MD | |
| Sub-Investigator: Ernesta Audisio, MD | |
| Medicina Interna I - Ospedale di Circolo | Not yet recruiting |
| Varese, (va), Italy | |
| Contact: Leonardo Campiotti, MD | |
| Principal Investigator: Leonardo Campiotti, MD | |
| Onco-Ematologia - Ospedale Civile | Not yet recruiting |
| Noale, (ve), Italy | |
| Contact: Giovanni Bertoldero, MD | |
| Principal Investigator: Giovanni Bertoldero, MD | |
| Ematologia - Ospedale San Bortolo | Recruiting |
| Vicenza, (vi), Italy | |
| Contact: Eros Di Bona, MD | |
| Principal Investigator: Eros Di Bona, MD | |
Sponsors and Collaborators
Northern Italy Leukemia Group
Investigators
| Study Chair: | Renato Bassan, MD | USC Ematologia, Ospedali Riuniti, Bergamo (Italy) |
More Information
No publications provided
| Responsible Party: | Dr Renato Bassan, NILG-USC Ematologia, Ospedali Riuniti, Bergamo (Italy) |
| ClinicalTrials.gov Identifier: | NCT00795756 History of Changes |
| Other Study ID Numbers: | NILG-ALL 10/07 |
| Study First Received: | November 19, 2008 |
| Last Updated: | March 31, 2011 |
| Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
Keywords provided by Northern Italy Leukemia Group:
|
Adults Central nervous system prophylaxis Minimal residual disease |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasm, Residual Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Neoplastic Processes Pathologic Processes Cytarabine Methotrexate Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Dermatologic Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013